Quality and Safety Management System Development for Medical Laboratories, Blood Banks and Establishments, Tissues and Cell Establishments

Quality and Safety Management Systems (QSMS)

Health Care Informed can assist in an organisation's understanding, implementation and development of an effective Quality and Safety Management System that meets the required regulations as well providing a strong organisational structure.

The QSMS, including all policies and procedures, can be developed to meet the applicable requirements, including but not exclusively:

  • S.I.158:2006 - European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006
  • S.I.598:2007 - Euopean Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007.
  • S.I.360:2005 – European Communities (Quality and Safety of Human Blood and Blood Components) Regulations 2005.
  • ISO15189:2003 – Medical laboratories Particular requirements for quality and competence.

Other services provided by Health Care Informed in relation to the QSMS include:

  • Implementation of a QMS documentation support system using the Q-Pulse software systems.
  • Non-conformance, incident reporting and Corrective and Preventative Action support tools.
  • Guidance on validation activity, including cleanroom and equipment validation review.
  • Completion of system gap analysis against applicable national and international standards.
  • Guidance on development of Outsource Models.

Auditing

Health Care Informed can provide qualified auditors to complete internal and Supplier Audit activities for your organisation or prepare your company for audit by external parties. Audit activities will be completed in accordance to ISO19011:2002 Guidelines for quality and/or environmental management systems auditing.

Risk Management

Risk Management is and area of primary importance for laboratories, requiring that all processes are appropriately assessed and effective control actions implemented. Health Care Informed can assist in the implementation of proven Risk Management Tools which will drive proactive responses.

Training

Training can be provided for the following:

  • Introduction and application of ISO 15189:2003 and S.I. 360:2005, or specific elements within these.
  • Internal or Supplier Auditing practice - completed in accordance to ISO9011:2003 to meet requirements of ISO 15189:2003 and S.I. 360:2005.
  • Risk Management – Processes and Tools.
  • Q-Pulse – implementation and system development.
  • Any element of the QSMS services provided by HCI

For more information contact us today info@hci.ie